Bristol Myers Squibb · 2 days ago
Associate Director, US Commercial Regulatory Affairs - Advertising and Promotion (Hybrid)
Madison, NJ
Full-time
Hybrid
Lead/Staff, Director/Executive
$173K/yr - $210K/yr
5+ years expBristol Myers Squibb is a company dedicated to transforming patients' lives through science. They are seeking an Associate Director for US Commercial Regulatory Affairs to provide regulatory advice and risk assessment for promotional campaigns and materials, ensuring compliance with applicable regulations and guidelines.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area
Provides solution-oriented and innovative advice to meet the company's objectives and goals
Provide strategic advice for the development of Advertising and Promotional Labeling Branch (APLB) and Office Of Prescription Drug Promotion (OPDP) advisory submissions and subpart E and H submissions
Ensure full regulatory compliance of all promotions with approved labeling and /or FDA guidances
Ensure regulatory compliance with subpart E/H and 2253 regulations
Lead training for Commercial teams on subpart E/H, 2253 regulations and FDA regulations on advertising and promotion
Ensure monitoring and maintenance of knowledge of the evolving regulatory landscape to provide innovative solutions and advice
Pursues and understands diverse perspectives inside and outside BMS to provide risk assessment and mitigation strategies
Develop and maintain strong working relationships with internal customers, including Commercial, Medical, Public Affairs, Legal and Compliance
Integrate compliance considerations into risk assessment by partnering with Legal/Compliance colleagues
Provide advice and guidance as appropriate on the development of draft product labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based
Provide input on process improvement and BMS guiding principles as needed
Engages with colleagues within the department to help support them in their roles and development
Provide direct management to individuals depending on assignment
Proactively seeks opportunities to learn and develop leadership skills
Qualification
Required
BS required; advanced degree preferred (MS, PhD, PharmD, JD)
Minimum of 3-5 years Regulatory promotional review or related 5 to 8 years pharmaceutical experience (e.g., Medical promotional review)
Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed products and strong interest in FDA advertising and promotion regulations including guidance(s)
Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns
Proven aptitude to analyze and interpret efficacy and safety data
Experience communicating and negotiating with OPDP/APLB
Organizational skills and ability to pay attention to details. Demonstrated ability to negotiate and influence others to help build team collaboration
Excellent verbal, communication, and presentation skills
Excellent interpersonal skills, flexibility, adaptable to a changing environment and adeptness to communicate effectively with cross functional teams and with business partners across the company
Benefits
Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Paid Time Off
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2026-01-08
2026-01-07
2026-01-07
Company data provided by crunchbase